Abstract
Several clinical trials have substantiated the efficacy of the co-administration of statins like atorvastatin (ATO) and fibrates. Without information currently available about the interaction between the two drugs, a pharmacokinetic study was conducted to investigate the effect when both drugs were co-administered. The purpose of this study was to investigate the pharmacokinetic profile of tablets containing ATO 20 mg, or the combination of ATO 20 mg with fenofibrate (FNO) 160 mg administered to healthy Mexican volunteers. This was a randomized, two-period, two-sequence, crossover study; 36 eligible subjects aged between 20–50 years were included. Blood samples were collected up to 96 h after dosing, and pharmacokinetic parameters were obtained by non-compartmental analysis. Adverse events were evaluated based on subject interviews and physical examinations. Area under the concentration-time curve (AUC) and maximum plasma drug concentration (Cmax) were measured for ATO as the reference and ATO and FNO as the test product for bioequivalence design. The estimation computed (90% confidence intervals) for ATO and FNO combination versus ATO for Cmax, AUC0-t and AUC0-∞, were 102,09, 125,95, and 120,97%, respectively. These results suggest that ATO and FNO have no relevant clinical-pharmacokinetic drug interaction.
Highlights
Has been shown that monotherapy affect lipid parameters favorably, combination therapy is often necessary for comprehensive management of dyslipidemias
The purpose of this study was to investigate the pharmacokinetic profile of tablets containing ATO 20 mg, or the combination of ATO 20 mg with fenofibrate (FNO) 160 mg administered to healthy Mexican volunteers
ANALYTICAL METHOD Atorvastatin were quantified with a method of UPLC-MS/MS, using an analytical method developed and validated, through a technique of liquid–liquid extraction
Summary
Has been shown that monotherapy affect lipid parameters favorably, combination therapy is often necessary for comprehensive management of dyslipidemias. Co-administration of atorvastatin (ATO) and fenofibrate (FNO) have shown beneficial effects in some patients by allowing simultaneous reduction of triglycerides and low-density lipoprotein cholesterol (Kiortisis et al, 2000; Athyros et al, 2002; Koh et al, 2005; Davidson et al, 2009; Pfizer Inc. Lipitor®, 2009). Pharmacokinetic drug interactions have been observed between statins and gemfibrozil, a commonly used fibrate currently on the market (Bergman et al, 2004). The potential for drug interactions must be taken into consideration. Atorvastatin a member of a lipid-lowering family of agents called statins, is a synthetic reversible inhibitor of 3-hydroxy-
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